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temsirolimus

What is the most important information I should know about temsirolimus?

You should not use temsirolimus if you have severe liver disease.

What is temsirolimus?

Temsirolimus is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Temsirolimus is used to treat cancer of the kidneys, also called renal cell carcinoma.

Temsirolimus may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before receiving temsirolimus?

You should not use temsirolimus if you are allergic to it, or if you have:

severe liver disease.

To make sure temsirolimus is safe for you, tell your doctor if you have ever had:

liver disease;

kidney disease;

high cholesterol or triglycerides (a type of fat in the blood);

diabetes;

a head injury, stroke, or brain tumor; or

an allergy to sirolimus (Rapamune).

Temsirolimus can harm an unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine, whether you are a man or a woman. Temsirolimus use by either parent may cause birth defects.

Keep using birth control for at least 3 months after your last dose of temsirolimus. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using temsirolimus.

It is not known whether temsirolimus passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How is temsirolimus given?

Temsirolimus is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. Temsirolimus must be given slowly, and the IV infusion can take up to 60 minutes to complete.

Temsirolimus is usually given once each week unless your cancer progresses or you have serious side effects from this medicine.

You may be given medication to prevent certain side effects while you are receiving temsirolimus.

Temsirolimus can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your kidney function may also need to be tested. Your cancer treatments may be delayed based on the results of these tests.

If you need surgery, tell the surgeon ahead of time that you are using temsirolimus.

What happens if I miss a dose?

Call your doctor if you miss an appointment for your temsirolimus injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while receiving temsirolimus?

Do not receive a "live" vaccine while using temsirolimus, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Grapefruit and grapefruit juice may interact with temsirolimus and lead to unwanted side effects. Avoid the use of grapefruit products while taking temsirolimus.

This medicine can pass into body fluids (urine, feces, vomit). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

What are the possible side effects of temsirolimus?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver right away if you feel dizzy, warm, tingly, light-headed, or short of breath.

Side effects such as diarrhea, swelling, and breathing problems may be more likely in older adults.

Common side effects may include:

rash;

nausea, loss of appetite;

swelling;

mouth sores or ulcers;

fever, weakness, flu symptoms; or

abnormal liver or kidney function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect temsirolimus?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can interact with temsirolimus. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:

This list is not complete and many other drugs can interact with temsirolimus. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

Your doctor or pharmacist can provide more information about temsirolimus.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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